MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE; CYSTO-URETHRO-FIBERSCOPE

Model Number 11272C1

Device Problem Calcified (1077)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that there was an issue with the front cover of the product (defective).Infections occurred several times after endoscopy.Due to the reported possible infections (causality not confirmed) the risk for serious deterioration in state of health is not negligible.

• Brand Name: FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE
• Type of Device: CYSTO-URETHRO-FIBERSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 18375032
• MDR Text Key: 331124546
• Report Number: 2020550-2023-00399
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 4048551226100
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11272C1
• Device Catalogue Number: 11272C1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other